Essure Sisters Discover Hundreds of FDA Data Errors

05/13/2016 - Since Essure came on the market, there have been thousands of adverse events reported to the FDA regarding injuries caused by the device. Consumers, the manufacturer or health care providers may file these adverse event reports. Many people believe that reports initiated by physicians and other health care providers are given more weight given the knowledge and authority of the source. However, a recent investigation into Adverse Event reports by physicians to the FDA revealed that tens of thousands of physician generated reports were being coded or entered into the system not reflecting the report were filed by physicians, but rather from a source identified as “other.” Physicians and nurses have reported more that 300 problems with Essure since August 2015 and the reporter’s occupation is listed as “other” on the reports.

The FDA blamed a computer glitch for the inconsistencies in its safety data. “The FDA became aware of a coding error that occurred during the upgrade of our adverse event reporting database in August of 2015,” said Deborah Kotz, an FDA spokeswoman, “It affected the ‘reporter occupation’ field in the database and resulted in the data field not correctly specifying whether the person filing the report was a doctor or nurse.” Madris Tomes, a former Food and Drug Administrator analyst, working on behalf of the Essure problems Group, discovered the FDA “glitch.” Had Ms. Tomes not discovered the glitch, the errors would have continued to go undetected, affecting tens of thousands of Adverse Event reports.

Ms. Tomes, founder of Device Events, together with the Essure Problems Group have uncovered other significant problems with the FDA Adverse Event Reporting System. Recently, the group discovered that although the FDA maintained there had only been five fetal deaths associated with Essure, there were in fact over 300 fetal deaths. When confronted with the discrepancy, the FDA admitted to same. Additionally, just recently Ms. Tomes uncovered that Bayer and the FDA knew that the pregnancy risk associated with Essure was significantly higher than what had been reported by Bayer at the September 24, 2015 advisory committee hearing.

At the hearing, the FDA announced that Bayer had reported 748 pregnancies through the end of 2010. Bayer’s mouthpiece, Dr. Edio Zampaglione, once again sang the party line that Essure’s efficacy rate is greater than 99% with only “a small number of pregnancies occurring.” However, both Bayer and the FDA were aware that the number of reported pregnancies was much higher. In fact, Ms. Tomes found an internal Bayer report filed with the FDA revealing that when the Bayer searched its database in March 2015 it found 2,028 reports of pregnancy with Essure.

It is apparent that both Bayer and the FDA were aware of the number of reported pregnancies long before the advisory meeting and willfully chose to engage in systemic cover-ups. This is not surprising as Bayer’s predecessor, Conceptus also failed to report over 30,000 Essure related complaints to the FDA. This of course begs the question, what else are Bayer and the FDA withholding regarding the dangers of Essure? The law firm of Ennis & Ennis, P.A. intends to find out. The firm has recently filed over 175 Essure lawsuits and looks forward to uncovering all the facts necessary to hold Bayer responsible to the thousands of women harmed by this device.


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